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Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation

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ClinicalTrials.gov Identifier: NCT01004107
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

Brief Summary:
The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.

Condition or disease Intervention/treatment Phase
Aging Hands Device: Radiesse Injectable Dermal Filler Not Applicable

Detailed Description:

This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment.

This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
Study Start Date : October 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Device: Radiesse Injectable Dermal Filler
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier

Active Comparator: Delayed Treatment
Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months
Device: Radiesse Injectable Dermal Filler
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier




Primary Outcome Measures :
  1. Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand [ Time Frame: 3 months from baseline ]

    To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

    Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

    4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

    1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.


  2. ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand [ Time Frame: 3 months from baseline ]

    To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

    Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

    4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

    1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.


  3. ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject [ Time Frame: 3 months from baseline ]

    To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

    Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

    4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

    1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.



Secondary Outcome Measures :
  1. Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand [ Time Frame: 3, 6, 9, and 12 months from baseline ]

    To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

    Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

    4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

    1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.


  2. ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand [ Time Frame: 3, 6, 9, and 12 months from baseline ]

    To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

    Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

    4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

    1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.


  3. ≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject [ Time Frame: 3, 6, 9, and 12 months from baseline ]

    To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.

    Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:

    4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;

    1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.


  4. Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only [ Time Frame: 3 months from baseline ]
    To evaluate the efficacy of Radiesse Injectable Dermal Filler for hand treatment as measured by a Global Aesthetic Improvement Scale (GAIS), by hand, as completed by three, blinded evaluators.

  5. Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only [ Time Frame: 3 months from baseline ]
    Effectiveness was measured by evaluating changes in hand appearance, by subject, using the GAIS completed by three, blinded evaluators

  6. Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    To evaluate the efficacy of Radiesse for hand treatment as measured by Global Aesthetic Improvement Scale (GAIS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators.

  7. Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Over Study [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    Effectiveness was measured by evaluating changes in hand appearance, by subject, between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects using the GAIS completed by three, blinded evaluators

  8. Physician Satisfaction Evaluation [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among physicians between baseline and 3, 6, 9 and 12 months, by subject

  9. Patient Satisfaction Evaluation [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among subjects between baseline and 3, 6, 9 and 12 months

  10. Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments [ Time Frame: 3, 6, 9, and 12 months from baseline ]
    Effectiveness was measured by evaluating subject's likelihood of return for additional Radiesse hand treatments at 3, 6, 9 and 12 months

  11. Mean Hand Function Rating During Prior Week [ Time Frame: Baseline and 3, 6, 9, and 12 months post-treatment ]

    Effectiveness was measured by evaluating subject's hand function during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Questions were as follows and were graded by subject as 1 = very good, 2 = good, 3 = fair, 4 = poor, and 5 = very poor:

    1. Overall, how well did you hand work?
    2. How well did your fingers move?
    3. How well did your wrist move?
    4. How was the strength in your hand?
    5. How was the sensation (feeling) in your hand?

  12. Difficulty Performing Activities During Prior Week [ Time Frame: Baseline and 3, 6, 9, and 12 months post-treatment ]

    Effectiveness was measured by evaluating subject's difficulty in performing routine activities during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:

    1. Turn a knob
    2. Pick up a coin
    3. Hold a glass of water
    4. Turn a key in a lock
    5. Hold a frying pan

  13. Difficulty Performing Activities During Prior Week, Both Hands [ Time Frame: Baseline and 3, 6, 9, and 12 months post-treatment ]

    Effectiveness was measured by evaluating subject's difficulty in performing routine activities, that require both hands, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:

    1. Open a jar
    2. Button a shirt / blouse
    3. Eat with a knife and fork
    4. Carry a grocery bag
    5. Wash dishes
    6. Wash your hair
    7. Tie shoelaces / knots

  14. Normal Work During Prior Week Evaluation [ Time Frame: Baseline and 3, 6, 9, and 12 months post-treatment ]

    Effectiveness was measured by evaluating subject's ability to work normally, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = always, 2 = often, 3 = sometimes, 4 = rarely, and 5 = never:

    1. How often were you unable to do your work because of problems with your hand(s) / wrist(s)?
    2. How often did you have to shorten your work day because of problems with your hand(s) / wrist(s)?
    3. How often did you have to take it easy at your work because of problems with your hand(s) / wrist(s)?
    4. How often did you accomplish less in your work because of problems with your hand(s) / wrist(s)?
    5. How often did you take longer to do tasks in your work because of problems with your hand(s) / wrist(s)?



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Has right and left hands with a rating of 3 or 4 on the Busso Hand Volume Severity Scale (BHVSS) as determined by the treating physician
  • Signs a written informed consent
  • Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through 12 month follow up
  • Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits

Exclusion Criteria

  • Has history of hypertropic scarring
  • Has a known bleeding disorder or receiving medication that will increase the risk of bleeding as the result of injection
  • Has a known hypersensitivity to any of the components of Radiesse or local anesthesia
  • Has used predefined products or treatments on the dorsum of the hand within last 4 weeks or intends to use during study
  • Has had any dermal fillers or surgery in the dorsum of the hand
  • Is a female of child bearing potential and not using medically effective birth control or is pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004107


Locations
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Germany
Merz Investigative Site #001
Munich, Germany
Merz Investigative Site #002
Munich, Germany
Merz Investigative Site #003
Munich, Germany
Merz Investigative Site #004
Munich, Germany
Sponsors and Collaborators
Merz North America, Inc.

Publications:
Busso M,et al. Multi-center Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxlapatite For Hand Rejuvenation. Derm Surg 2010; 36:790-797

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Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT01004107     History of Changes
Other Study ID Numbers: P0508332
First Posted: October 29, 2009    Key Record Dates
Results First Posted: July 13, 2018
Last Update Posted: July 13, 2018
Last Verified: September 2017